PHARMO Institute Seroquel Safety Study
PHARMO II
Seroquel Safety Study
1 other identifier
observational
18,325
0 countries
N/A
Brief Summary
The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedSeptember 2, 2011
August 1, 2011
2 months
April 21, 2011
August 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs
Study Arms (4)
Quetiapine
Quetipine users
All other atypical antipsychotics
All other atypical antipsychotics users
Risperidone
Risperidone users
Olanzapine
Olanzapine users
Eligibility Criteria
Population based sample of about 2.5 millions residents in the Netherlands
You may qualify if:
- Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.
You may not qualify if:
- less than a year of recorded history before the cohort entry date
- use of multiple antipsychotics concomitantly
- duration and dose of the antipsychotic drug cannot be determined
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- PHARMO Institute for Drug Outcomes Researchcollaborator
Related Publications (1)
Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Post authorization safety study comparing quetiapine to risperidone and olanzapine. Hum Psychopharmacol. 2016 Jul;31(4):304-12. doi: 10.1002/hup.2539. Epub 2016 Jun 13.
PMID: 27297785DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edith Heintjes
PHARMO Institute for Drug Outcomes Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 27, 2011
Study Start
September 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 2, 2011
Record last verified: 2011-08